double-blind randomized parallel group study comparing the efficacy and safety of tiotropium and ipratropium in the treatment of copd patients in taiwan

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ID: 221620
2006
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Abstract
To compare the efficacy and safety of tiotropium and ipratropium in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. Methods: This double-blind, randomized, placebo-controlled, parallel group study was conducted at six hospitals in Taiwan. COPD patients aged ≥ 40 years, with a forced expiratory volume in 1 second (FEV1) ≤65% of predicted and FEV1/forced vital capacity (FVC) ≤ 70% were enrolled. After a 2-week screening/baseline period, 132 patients were randomized to receive 4 weeks of treatment with either tiotropium 18 μg once daily from a dry powder inhaler (HandiHaler(r)) or two puffs of ipratropium 20 μg four times daily from a metered dose inhaler. The primary outcome was the change in trough FEV1 from baseline to week 4. The secondary outcome measures were trough FVC response, FEV1 and FVC responses at 2 hours postinhalation. Results: After 4 weeks, trough FEV1 had increased by 61.7 + 25.3 mL for tiotropium but decreased by 16.4 + 27.9 mL for ipratropium. The difference between groups was significant (p<0.05; 95% CI, 10-146.1). The trough FVC also increased by 137.2 + 49.3 mL for tiotropium but was decreased by 84.5 + 54.5 mL for ipratropium (p< 0.001; 95% CI, 89.0-354.3). No major drug-related adverse events associated with tiotropium and ipratropium were observed. Conclusion: Tiotropium 18 μg once daily using HandiHaler(r) was significantly more effective than ipratropium 40 p, g four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable.
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Authors ;Jeng-Yuan Hsu;Reury-Pemg Perng;Jau-Yeong Lu;Chin-Pyng Wu;Ming-Shyan Huang;Kwen-Tay Luh;Pan-Chyr Yang
Journal Bioorganic & medicinal chemistry letters
Year 2006
DOI
10.1016/S0929-6646(09)60198-4
URL
http://www.sciencedirect.com/science/article/pii/S0929664609601984
Keywords
chronic obstructive pulmonary disease tiotropiummedicine (general)

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